Core Viewpoint - Johnson Fistel, PLLP is investigating potential violations of federal securities laws by Soleno Therapeutics, Inc. and its officers regarding misleading statements and undisclosed material information to investors [1][2]. Group 1: Investigation Details - The investigation focuses on whether Soleno's communications accurately represented the commercial progress and safety profile of VYKAT™ XR after its FDA approval [2]. - Following the FDA clearance in September 2025, Soleno claimed that the product rollout was exceeding internal expectations [2]. Group 2: Earnings Call Insights - During the third-quarter earnings call on November 4, 2025, Soleno acknowledged challenges in the launch of VYKAT™ XR, including a slowdown in new treatment initiations and an increase in therapy discontinuations due to non-serious adverse events [3]. - Management indicated that external commentary earlier in the year had negatively impacted the launch trajectory [3]. Group 3: Short Seller Report - On August 15, 2025, Scorpion Capital released a report raising concerns about VYKAT™ XR, questioning its safety profile, demand sustainability, and the concentration of early prescribing activity [4]. - The report criticized Soleno's business model for being overly reliant on a single product with impending intellectual property expiration and suggested that certain clinical research needed further examination [4]. Group 4: Stock Price Volatility - Following the Scorpion report, Soleno's stock price experienced significant volatility, declining nearly 40% from August 14, 2025, to November 5, 2025 [5].

Core Insights - U.S. stocks showed mixed performance, with the Dow Jones index increasing by over 100 points on Tuesday [1] Company Performance - PubMatic Inc reported third-quarter earnings of 3 cents per share, surpassing the analyst consensus estimate of a loss of 10 cents per share, and quarterly sales of $67.960 million, exceeding the estimate of $63.768 million [1] - PubMatic shares surged by 33.2% to $10.19 following the positive earnings report [2] - Surmodics Inc experienced a gain of 49.3% to $40.85 after a court denied the FTC's attempt to block GTCR's acquisition [4] - enGene Holdings Inc's shares rose by 36.4% to $8.20 after reporting a 63% complete response rate in its Phase 2 LEGEND study [4] - Energy Vault Holdings Inc's stock increased by 33.1% to $4.72 following its third-quarter results [4] - RealReal Inc's shares climbed by 25.6% to $14.08 after reporting better-than-expected third-quarter results and raising its FY25 sales guidance [4] - Hallador Energy Co reported better-than-expected quarterly sales, leading to a 19.3% increase in its stock price to $23.87 [4] - BigBear.ai Holdings Inc's shares rose by 17.3% to $6.71 after announcing better-than-expected quarterly results and the acquisition of Ask Sage [4] - Paramount Skydance Corp's stock gained 10.9% to $16.92 after reporting third-quarter results and issuing optimistic fourth-quarter sales guidance [4] - Clearwater Analytics Holdings Inc's shares increased by 9.3% to $18.24 [4] - Rocket Lab Corp's stock rose by 8.3% to $56.27 after reporting better-than-expected third-quarter results and issuing positive fourth-quarter sales guidance [4] - Viasat Inc's shares gained 8.1% to $39.96 after an upgrade from JP Morgan analyst Philip Cusick, who raised the price target from $23 to $50 [4] - Soleno Therapeutics Inc's stock rose by 6.7% to $49.42 after announcing a $100 million accelerated share repurchase plan [4]

Summary of Soleno Therapeutics FY Conference Call Company Overview - **Company**: Soleno Therapeutics (NasdaqCM: SLNO) - **Industry**: Healthcare, specifically focusing on treatments for Prader-Willi Syndrome (PWS) and hyperphagia Key Financial Highlights - **Revenue**: Doubled to **$66 million** in the latest quarter [6] - **Cash Flow**: Achieved cash flow positive status [6] - **Market Share**: Captured **10%** of the total addressable market (TAM) within the first six months of launch [8][9] Core Insights and Arguments - **Market Expectations**: There was a disconnect between market expectations and actual performance, with investors expecting more immediate results from start forms [6][7] - **Start Forms Cadence**: Anticipated a steady increase in start forms over time, with normalization observed after an initial bullish phase [8][11] - **Long-term Market Potential**: The drug is projected to become a **billion-dollar** product in the near future [9] - **Buyback Program**: Announced a **$100 million** buyback program due to perceived undervaluation of the company's stock [10] Patient and Physician Engagement - **Discontinuation Rates**: Most discontinuations occur during the initial titration phase, often due to side effects such as peripheral edema and hyperglycemia [14][15] - **Education Initiatives**: Emphasis on educating both physicians and families to improve treatment adherence and understanding of the drug [16][17] - **Real-world Efficacy**: Maximal effects of the drug may take **six to nine months** to manifest, with early signs of efficacy being meaningful for patients [18] Market Dynamics - **Comorbidities Awareness**: Increased recognition among healthcare providers regarding the complexity of PWS and the need for careful patient management [20][24] - **Physician Education**: Ongoing efforts to enhance physician education through peer-to-peer interactions and expert consultations [32] European Market Strategy - **Regulatory Process**: Engaged with the European Medicines Agency (EMA) and expects a decision by **Q2** of the following year [35][37] - **Launch Preparation**: Plans to potentially launch in Europe independently, starting with Germany, while also considering partnerships [38] Coverage and Access - **Insurance Coverage**: Expanded coverage to **132 million lives**, with expectations to reach **80%** coverage in 12 to 18 months post-launch [42] - **Payment Success**: Positive payment trends observed from state Medicaid programs and major pharmacy benefit managers [42] Additional Considerations - **Patient Weight Trends**: Anticipated that patient weight may trend higher in the commercial setting compared to clinical trials [43] - **Dosing Strategy**: Patients will be titrated based on weight bands, with higher doses expected for larger patients [45] This summary encapsulates the key points discussed during the Soleno Therapeutics FY Conference Call, highlighting the company's performance, market strategy, and ongoing efforts to engage with healthcare providers and patients.

Core Insights - Soleno Therapeutics has authorized a $100 million share repurchase and entered into an Accelerated Share Repurchase Agreement with Jefferies LLC [1][2] - The company achieved profitability in Q3 2025 and believes its future cash generation potential is undervalued by the market [2] Financial Actions - The initial payment under the ASR agreement will be $100 million, with an initial delivery of approximately 1,511,553 shares based on the closing price on November 10, 2025 [2] - The final number of shares repurchased will depend on the average volume-weighted price during the transaction period and will be subject to adjustments [2] Product Information - Soleno's first commercial product, VYKAT XR, is an oral treatment for hyperphagia in patients with Prader-Willi syndrome, targeting both adults and children aged 4 and older [4]

Company Overview - Soleno Therapeutics is a biopharmaceutical company focused on developing innovative treatments for rare diseases [3]. Allegations and Impact - The FDA authorized Soleno's VYKAT XR (diazoxide choline) on March 26, 2025, for treating hyperphagia in patients aged four years and older with Prader-Willi syndrome [4]. - By November 4, 2025, Soleno reported an 8% discontinuation rate of the drug due to side effects and indicated that a short-seller report from mid-August had delayed the drug's rollout [4]. - Following these developments, Soleno's stock price experienced a decline of over 26% [4]. Legal Investigation - Edelson Lechtzin LLP is investigating potential violations of federal securities laws related to Soleno, stemming from allegations of providing misleading business information to investors [1].

Company Overview - Soleno Therapeutics, Inc. (NASDAQ: SLNO) is under investigation for potential violations of U.S. federal securities laws, focusing on whether the company and its executives made false or misleading statements or failed to disclose material information to investors [1][2]. Recent Developments - On March 26, 2025, Soleno announced FDA approval for VYKAT XR (diazoxide choline) extended-release tablets, intended for treating hyperphagia in individuals with Prader-Willi syndrome aged 4 and older [3]. - During a quarterly earnings call on November 4, 2025, Soleno disclosed a discontinuation rate of approximately 8% for VYKAT XR due to adverse effects by the end of Q3 2025. The CEO acknowledged a disruption in the product's launch trajectory following a short seller report released in mid-August, which led to a decrease in start forms and an increase in discontinuations for non-serious adverse events [4]. Market Reaction - Following the earnings call and the revelation of the discontinuation rate, Soleno's share price experienced a decline of over 26% [4].

Core Viewpoint - Soleno Therapeutics, Inc. experienced a significant drop in share price by $18.78 (-28%) following disappointing news regarding its drug VYKAT™ XR, which is intended to treat hyperphagia associated with Prader-Willi syndrome [1][2]. Company Performance - The company had previously assured investors of a successful launch of VYKAT™ XR after receiving FDA approval, stating that the launch "has been going really well" and "definitely exceeded our expectations" [2]. - However, during the Q3 2025 earnings call, Soleno disclosed a disruption in the launch trajectory, citing a lower number of start forms and increased discontinuations due to non-serious adverse events [2]. Market Reaction - Following the negative news, Soleno's share price fell nearly 40% from August 14, 2025, to November 5, 2025 [4]. - The market reaction was influenced by concerns raised by short seller Scorpion Capital, which highlighted potential risks associated with VYKAT™ XR, including reports of children hospitalized for heart failure after using the drug [3][4]. Investigations and Allegations - Hagens Berman, a national shareholders rights firm, is investigating whether Soleno misled investors regarding the commercial prospects of VYKAT™ XR [5]. - Scorpion Capital characterized Soleno as a "one-trick pony" with no other significant assets or pipeline, raising doubts about the company's future if VYKAT™ XR fails [3][4]. - Allegations were made regarding the integrity of clinical trial data and the influence of a controversial physician involved in key trials, suggesting potential irregularities in the company's disclosures [4].

Core Insights - Soleno Therapeutics Inc. (NASDAQ: SLNO) experienced a significant decline of 26.59% in stock price, closing at $46.87, marking the fifth consecutive day of losses as investors anticipated strong earnings for Q3 [1][3] - The company reported a net income of $26 million for the third quarter, a 134% improvement from a net loss of $76.6 million in the same period last year, with revenues reaching $66 million [2][3] Company Performance - The strong Q3 results are attributed to increased awareness of the efficacy and safety of Vykat XR, the first and only FDA-approved drug for hyperphagia, particularly within the Prader-Willi Syndrome (PWS) community [3][4] - Vykat XR is positioned as a critical treatment option for patients aged 4 years and older suffering from hyperphagia, addressing a complex patient population with serious co-morbidities [4]

Core Insights - Soleno Therapeutics has been upgraded to "Overweight" by Wells Fargo, with a revised price target of $106 from $123, while the stock price is currently at $63.85 [1][6] - The company reported a net revenue of $66 million and a net income of $26 million in Q3 2025, primarily driven by VYKAT XR sales [3][6] - Soleno has engaged 494 unique prescribers and has 764 active patients on VYKAT XR since its approval in March 2025 [3][6] Financial Performance - In Q3 2025, Soleno achieved net revenue of $66 million from VYKAT XR sales, resulting in a positive net income of $26 million [3][6] - The stock price has decreased by 2.74% today, with a trading range between $63.81 and $67.43, and a market capitalization of approximately $3.39 billion [4] Strategic Developments - Soleno has appointed Mark W. Hahn to its Board of Directors and Audit Committee to enhance its strategic direction and governance [5] - The company has covered over 132 million lives under its initiatives, indicating an expansion in its reach within the biopharmaceutical industry [5]

Core Viewpoint - U.S. stock futures are lower, with notable declines in several companies following disappointing financial results and guidance [1] Group 1: Super Micro Computer Inc - Super Micro Computer reported quarterly earnings of 35 cents per share, missing the analyst consensus estimate of 40 cents [2] - Quarterly revenue was $5.01 billion, below the analyst consensus estimate of $5.99 billion and down from $5.93 billion in the same period last year [2] - Shares of Super Micro Computer fell 9.2% to $43.12 in pre-market trading [2] Group 2: Other Companies with Significant Declines - Biohaven Ltd tumbled 46.2% to $7.51 after receiving an FDA Complete Response Letter for VYGLXIA [4] - Trex Company Inc declined 31.9% to $32.02 following worse-than-expected third-quarter results and lowered FY25 sales guidance [4] - Axon Enterprise Inc fell 19.6% to $567.50 after reporting mixed third-quarter results and announcing an acquisition agreement [4] - Pinterest Inc dipped 18.8% to $26.69 after posting disappointing third-quarter earnings [4] - Advanced Micro Devices, Inc. declined 5% to $237.80 despite reporting better-than-expected third-quarter results, with an expected fourth-quarter revenue of approximately $9.6 billion [4]